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GDP (Good Distribution Practice)


Training "GDP (Good Distribution Practice)"



Invited Trainers:



Dr. Werner Gielsdorf, HSC- Germany

General Manager of TACIS project of European Commission in CIS, Manager of UNCTAD, WTO, ITC ,

EU, World Bank, UNCTAD/WTO,

trainer of GCP, GLP, GDP,GMP


Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
Lehrman healthcare Council, First Clinical Research LLC Speakers
Bureau, former head of consulting Group of the Department of Clinical Research

( 2006-2008 ).


The pharmaceutical industry has the responsibility not only to manufacture effective and safe products, but also to ensure that they are delivered to the patient in a safe and controlled manner. Management of the supply chain is a critical activity which requires adequately designed facilities, documentation systems and trained staff. This training course will cover the regulatory requirements developed by the EU and USA regulators as well as the WHO (World Health Organisation). Delegates attending this course will be provided with information on how to design and manage warehouses, select contractors, temperature map their warehouse, develop temperature monitoring system and manage transportation of their products. In addition guidance will be given on preparing SOPs, documentation and preparing facilities for EU/USA regulatory inspections. Interactive workshops especially designed to enable participant exchange views, share experiences with others and, our expert tutor while being guided through key aspects of pharmaceutical supply chain management.


Course will be of interest to the following industries:

Pharmaceutical/veterinary manufacturers

Biotech manufacturers

Vaccine manufacturers

Suppliers of vaccines

Healthcare providers

Supplier of services to the above industries

Hospital management


Production managers

Qualified Persons/Responsible Persons

Project Managers

Procurement Managers

Quality Assurance managers/Quality Control Managers

Supplier Auditors

Regulatory Affairs Personnel

Distribution/Transport/Logistics Managers

Professionals from Distribution and Logistics Functions

Contract Warehouse Managers




Regulatory requirements

EU Directives

WHO Guidelines

EU Legislations on Wholesale Distribution

EU Guidelines for Wholesale Distribution Practice

Role of Qualified Person and Responsible Person



Premises and facilities

Facility design

Cleaning & ‘cleanability’

Security and product integrity

People movement

Materials movement

Product segregation

Control of contamination/cross contamination

Temperature control & Monitoring – what is required



Staff selection and qualification

GDP/GMP training

SOP Training

Training records



Quality Systems


Definitions Orders





Document control and maintenance

Document Archiving

Preparing training packages



Identifying what is required

how to develop a standard format and structure

writing SOPs

critical SOPs for a warehouse

preparing SOP training packages


Non Compliance Management

investigation of non-compliance

reporting and documentation

corrective action and preventive action planning (CAPA)


Returns Management

returns of non-defective medicinal products

security and QA decision


Emergency Planning and Recall

recall procedure

investigation and reporting

corrective action planning



facility requirement

control of product and facility contamination



Stock Management

cycle counting


Packaging & Re-labelling

facility and equipment requirements

SOPs and Documentation

staff training


Warehouse Management System

Developing specification

Vendor selection



Self Inspection

regulatory expectations


reporting and action planning



Decision process for outsourcing

Contractor selection process

Quality/Technical agreement

Contract considerations

Audits of contractors




Modes of transportation and challenges they offer Air





Vehicle design consideration

Security issues

Temperature monitoring & control

Non compliance reporting and action planning



Cold Chain Management

Developing specification

Facility design consideration

Transport issues

Packaging options

Monitoring during storage and transport

Developing procedures

Training and control

Dealing with out of specification situations


Temperature Mapping

What to consider when mapping your warehouse/trailer

Design considerations

Developing plans

Test protocols

Identifying the risk areas

Planting the temperature monitors

Collating data and data evaluation

Reporting – developing recommendations

How to maintain the qualified status -On going maintenance



Preparing for Inspections

Developing self inspection programme

Training issues

Internal audits

Action planning Root cause analysis

Preventive action



Maintaining inspection readiness status


Inspection findings

Most recent regulatory and client inspection findings





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Our Partners:


Sheraton Hotel Montazah


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Contract Research Organizations













good clinical


quality assurance1) Quality of our services confirmed by audits.

2) International level of GCP / GMP / ISO trainers and auditors.

3) You can check at any time any GCP / GMP / ISO certificate for authenticity.

medical training

06 July 2014

Current GDP Audit - contract research organization (CRO)



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Contracts signed with GMP / ISO auditors from the U.S.A.


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Gift for each medical conference participant: Flash drive 2 GB Kingston DataTraveler (DTI / 2Gb) !

iso certificate


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gdp certificate


in United Kingdom:

NBScience limited,

788-790 Finchley Road,

London, NW11 7TJ,

United Kingdom

Registered company number: 7083138


good manufacturing Skype: ich-gcp




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